Page 1/9 Safety Data Sheet © Abbott Laboratories Release date 05/29/2017 Last alteration on 05/29/2017 1 Identification · Product name: iSTAT CKMB Control Level 1 / iSTAT CKMB Control Level 2 / iSTAT CKMB Control Level 3 / iSTAT CKMB CalVer Control Level 1, 2 & 3 · ADD List number: 06P17-01 06P17-02 06P17-03 06P17-04 · Application of the substance / mixture: For In Vitro Diagnostic Use · Manufacturer / Supplier: Abbott Diagnostics 100 Abbott Park Road Abbott Park, IL 60064-3500 Phone: 1-877-4 ABBOTT · Department issuing SDS: Abbott Diagnostics Environmental Health and Safety · Emergency telephone number Contact the CHEMTREC® Emergency Call Center for assistance with transportation or hazardous materials emergencies (24 hours/day, 7 days/week). Refer to Abbott customer number 675922. - Telephone (800) 424-9300 (toll-free) if you are calling from within the United States, Canada, Puerto Rico and the Virgin Islands. - Telephone +1 (703) 527-3887, the international and maritime number (collect calls accepted), if you are calling from outside the United States or from a ship at sea. 2 Hazard(s) identification · Classification of the substance or mixture This product has been evaluated per the classification criteria in the Globally Harmonized System of Classification and Labelling of Chemicals (GHS). This product does not meet the criteria for classification in accordance with the GHS. · Label elements · GHS label elements: none · Hazard pictograms: none · Signal word: none · Hazard statements: none · Precautionary statements: P501 Dispose of contents / container in accordance with local regulations. · Routes of Exposure: For bloodborne pathogens and potentially infectious materials: - non-intact skin - mucous membranes (which includes, but is not limited to, the lining of the nose, mouth and throat) - parenteral contact (e.g. by injection, puncture) · Hazard Overview · Health: No adverse effects expected if used as directed. · Fire: Noncombustible USA 44.4.8 Page 2/9 Safety Data Sheet © Abbott Laboratories Release date 05/29/2017 Last alteration on 05/29/2017 Product name: iSTAT CKMB Control Level 1 / iSTAT CKMB Control Level 2 / iSTAT CKMB Control Level 3 / iSTAT CKMB CalVer Control Level 1, 2 & 3 · Reactivity: Minimal hazard - Stable, even in a fire. Not reactive with water. Not an oxidizer. · Other hazards This product contains potentially infectious material. Refer to the US OSHA Bloodborne pathogens standard (29 CFR 1910.1030) for additional relevant information. 3 Composition/information on ingredients · Chemical characterization: Mixture of chemical and/or biological substances for in vitro diagnostic use. · Hazardous chemical ingredients per U.S. OSHA criteria (29 CFR 1910.1200 Hazard Communication): CAS: 26628-22-8 Sodium azide 0.09% 4 First-aid measures · After inhalation: Remove from source of exposure. Seek medical attention and appropriate follow-up. · After skin contact: Take off any clothing that the product touched. Wash affected area with soap and water. Seek medical attention and appropriate follow-up. · After eye contact: Rinse open eye(s) cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. Seek medical attention and appropriate follow-up. Wash hands after handling. · After swallowing: Rinse mouth with water. Seek medical attention and appropriate follow-up. · Information for Medical Personnel This product contains human sourced and/or potentially infectious components. See package insert / instructions for use for details. No known test method can offer complete assurance that products derived from human sources or inactivated microorganisms will not transmit infection. · Most important symptoms and effects, both acute and delayed: None expected · Medical conditions aggravated by exposure: Pre-existing respiratory ailments None known 5 Fire-fighting measures · Suitable extinguishing agents Dry chemical, carbon dioxide (CO2), water spray or regular foam. - Caution: CO2 will displace air in confined spaces and may cause an oxygen-deficient atmosphere. - For larger fires: There are no unique chemical or reactivity hazards that would impact firefighting decisions related to this product. Use firefighting measures that suit the environment. · Special hazards arising from the substance or mixture There are no unique chemical or reactivity hazards that would impact firefighting decisions due to the chemicals in this product. USA 44.4.8 Page 3/9 Safety Data Sheet © Abbott Laboratories Release date 05/29/2017 Last alteration on 05/29/2017 Product name: iSTAT CKMB Control Level 1 / iSTAT CKMB Control Level 2 / iSTAT CKMB Control Level 3 / iSTAT CKMB CalVer Control Level 1, 2 & 3 · Protective equipment For large fires, wear appropriate heat- and flame-resistant personal protective equipment and a NFPA/NIOSH approved positive-pressure, self-contained breathing apparatus. 6 Accidental release measures · Personal precautions, protective equipment and emergency procedures Handle as a potentially infectious material. Minimize exposure by using appropriate personal protective equipment as listed in Section 8. Stop leak if possible. Keep unprotected persons away. · Environmental precautions Prevent liquid and vapor from entering sewage system, storm drains, surface waters, and soil. · Methods and material for containment and cleaning up Blot up small volumes of spilled or spattered product with paper towels or similar materials. - Contain larger spills by placing absorbants around the outside edges of the spill. Absorb with any material suitable for water-based liquids - e.g. paper towels, universal sorbents, sand, diatomite, sawdust, etc. Clean the affected area. Suitable cleaners are: - warm water and detergent or similar cleansing agent Apply a suitable disinfectant. Select a disinfectant that is effective against bloodborne infectious agents, as well as other microbial agents that you might expect to be prevalent in your population. A disinfectant that is effective against Mycobacterium tuberculosis is generally effective against all known viruses and non-sporeforming bacteria, and is suitable for most clinical laboratory situations. NOTE: Commercial disinfectants must be used according to manufacturer directions. Disinfectants are typically hazardous chemicals that react with many chemicals, materials and living tissues. Obtain and review the manufacturer’s safety information before using the disinfectant. This product contains sodium azide, which is toxic and reactive. See Sections 10 and 13 for additional information that could affect handling and disposal of contaminated spill materials. NOTE FOR LARGE-VOLUME SPILL: This product contains sodium azide, which reacts with acid to liberate hydrazoic acid, a very toxic gas. Select a disinfectant with the following properties if disinfection of materials used to absorb a large volume of spilled product is required: - Do not use any chemical or product with a pH below 6 to disinfect waste that contains sodium azide. Hydrazoic acid, a toxic gas, will be released when the pH is lower than 6. - Do not use any chemical or product that contains mercury or any other metal to disinfect waste that contains sodium azide. This will create metal azide compounds, which can be highly explosive under pressure or shock (percussion). - Select a disinfectant that does not bubble, effervesce or otherwise generate aerosols. - Do not use excess disinfectant. - Failure to follow manufacturer’s directions may lead to unexpected reactions with the waste. - Do not use a disinfectant if you do not have the proper facility, equipment and other appropriate protective measures available to work with it safely. Dispose of spilled and contaminated material in accordance with Federal, State, and Local regulations. See Section 13 for information that may impact disposal of materials contaminated with this product. · Reference to other sections See Section 7 for information on safe handling. See Section 8 for information on personal protection equipment. USA 44.4.8 Page 4/9 Safety Data Sheet © Abbott Laboratories Release date 05/29/2017 Last alteration on 05/29/2017 Product name: iSTAT CKMB Control Level 1 / iSTAT CKMB Control Level 2 / iSTAT CKMB Control Level 3 / iSTAT CKMB CalVer Control Level 1, 2 & 3 See Section 13 for disposal information. 7 Handling and storage · Precautions for safe handling: Handle as a potentially infectious material. · Information about protection against explosions and fires: The product is not flammable. · Requirements to be met by storerooms and receptacles: Store only in the original container. Refer to the package insert or product label for additional information on storage conditions for product quality. · Information about storage in one common storage facility: Store in original packaging. · Further information about storage conditions: Protect from heat and direct sunlight. 8 Exposure controls/personal protection · Components with Occupational Exposure Limits CAS: 67-56-1 Methanol (1.00 %) PEL TWA: 260 mg/m³, 200 ppm REL STEL/C: 325 mg/m³, 250 ppm TWA: 260 mg/m³, 200 ppm Skin TLV STEL/C: 328 mg/m³, 250 ppm TWA: 262 mg/m³, 200 ppm Skin; BEI CAS: 56-75-7 Chloramphenicol (0.10 %) WEEL TWA: 0.5 mg/m³ CAS: 26628-22-8 Sodium azide (0.09 %) REL Ceiling limit value: 0.3** mg/m³, 0.1* ppm *as HN3; **as NaN3; Skin TLV Ceiling limit value: 0.29** mg/m³, 0.11* ppm *as HN3 vapor **as NaN3 · Ingredients with biological limit values: CAS: 67-56-1 Methanol (1.00 %) BEI 15 mg/L Medium: urine Time: end of shift Parameter: